Rules on the contracts with manufacturers required for the management of the Union antigen, vaccine and diagnostic reagent banks
Article 3
1. The Commission shall conclude contracts with selected manufacturers in order to manage, for category A diseases as referred to in Article 3 of Commission Implementing Regulation (EU) 2022/140, the following banks: (a) Union antigen banks; (b) Union vaccine banks; (c) Union diagnostic reagent banks. 2. The Commission shall implement a public procurement procedure, in accordance with the rules laid down in Regulation (EU, Euratom) 2018/1046, for the selection of the manufacturers for the contracts referred to in paragraph 1. 3. The contracts referred to in paragraph 1 shall cover at least the following matters: (a) conditions for the supply of various quantities and types of antigens, vaccines or diagnostic reagents to the Union antigen, vaccine and diagnostic reagent banks; (b) conditions for the secure storage and replacement of antigens, vaccines or diagnostic reagents; (c) in the case of Union antigen banks, guarantees and conditions for: (i) the rapid formulation of the antigens into vaccines; (ii) the production, bottling and labelling of vaccines reconstituted from the antigens; (d) conditions for the release, shipment and delivery of vaccines or diagnostic reagents; (e) conditions for the destruction and safe disposal of the antigens, vaccines or diagnostic reagents, or for the buy-back of antigens, for which the validity period has expired.